Kornimate/medical-research-clean huggingface dataset:
oral mucosal lesions among smokers in an egyptian population study.

Conditions: Smokers

Summary: this cross-sectional study will assess the prevalence of oral changes among smokers in an egyptian cohort (patients attending to the hospital of faculty of dentistry - cairo university), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in egypt

the participants will be selected from the pool of the clinics of oral medicine, periodontology and diagnosis department and the diagnostic center, faculty of dentistry - cairo university. for each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Eligibility criteria:
inclusion criteria: * gender: males and females. * age: all age groups. * smokers. * individuals who agreed to sign the informed consent. exclusion criteria: * individuals suffering from any systemic disease. * individuals on medications. * non-egyptians.
evaluate the efficacy and safety of abt-126 in subjects with mild to moderate alzheimer's disease on stable doses of acetylcholinesterase inhibitors

Conditions: Alzheimer's Disease

Summary: this is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate alzheimer's disease.

this is a phase 2 study designed to evaluate the efficacy and safety of abt-126 in approximately 420 adults with mild to moderate alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. subjects will be randomized to one of two abt-126 dose arms or placebo for a 24-week treatment period.

Eligibility criteria:
inclusion criteria: * the subject and caregiver must voluntarily sign and date an informed consent. if the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. * the subject is a male or female between the ages of 55 and 90 years, inclusive, at screening visit 1. main inclusion (continued): * the subject meets the neurological and communicative disorders and stroke/alzheimer's disease and related disorders association (nincds/adrda) criteria for probable ad. * the subject must be receiving a stable dose of an achei (donepezil or rivastigmine) for at least 90 days prior to screening visit 1. * the subject has a mini-mental status examination (mmse) total score of 12 to 24, inclusive, at screening visit 1. * the subject has a cornell scale for depression in dementia (csdd) score ≤ 10 at screening visit 1. * the subject has a modified hachinski ischemic scale (mhis) score of ≤ 4 at screening visit 1. * with the exception of a diagnosis of mild-to-moderate alzheimer's disease and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ecg). * the subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study. exclusion criteria: * the subject has taken galantamine or memantine within 60 days prior to screening visit 1. * the subject has received excluded concomitant medications. * the subject has clinically significant abnormal laboratory values at screening visit 1 as determined by the investigator. * the subject has a history of any significant neurologic disease other than alzheimer's disease including parkinson's disease, multi-infarct or vascular dementia, huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. * in the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
phase 2a study to evaluate safety and explore efficacy of j2h-1702 for nash

Conditions: Non-alcoholic Steatohepatitis

Summary: the study aims to evaluate the safety of j2h-1702 compared to the placebo and explore the efficacy of j2h-1702 at week 12 timepoint after administration compared to baseline in patients with nash.

subjects will be randomized to the study group 1 (j2h-1702 a mg), study group 2 (j2h-1702 b mg), study group 3 (j2h-1702 c mg), or control group (placebo of j2h-1702) in a 1:1:1:1 ratio and administered the investigational product (ip) for 12 weeks. after the ip administration, the safety and efficacy will be evaluated at v4, v8 and v12 (end of treatment, eot).

Eligibility criteria:
inclusion criteria: 1. a subject aged ≥19 years to ≤75 years 2. meeting all of the following criteria: * screening mri-pdff with ≥8% steatosis * screening mre with liver stiffness ≥2.5 kpa * alt or ast ≤250 iu/l at screening 3. willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study 4. voluntarily provide written consent to participate in the study exclusion criteria: 1. a subject who has past or current history of liver diseases 2. a subject who has the following medical or surgical history * severe cardiac diseases, malignant tumors, clinically significant hypersensitivity reaction to any drugs containing components of the 11β-hsd1 inhibitor or same class 3. a subject who has the following concomitant diseases * liver disease, uncontrolled hypertension, uncontrolled dm, etc. 4. a subject who has taken the following medications * systemic glucocorticoids, nsaids, any medication that may induce fatty liver disease, etc. 5. a subject who has taken ip of another study 6. a subject who does not agree with appropriate methods of contraception
prospective evaluation of needle exsufflation for pneumothorax

Conditions: Pneumothorax

Summary: monocentric observational study of needle exsufflation for pneumothorax in the icu.

the main objective of this prospective observational non interventional study is to investigate a possible relationship between prior duration of pneumothorax (defined as the duration from first occurence of chest pain reported by patient to exsufflation) and the success of exsufflation procedure (defined by the absence of a chest tube insertion in the following 24h).

Eligibility criteria:
inclusion criteria: * adult icu patients requiring needle exsufflation for spontaneous pneumothorax exclusion criteria: * refuse to participate * contraindications to needle exsufflation (acute respiratory failure requiring immediate chest tube insertion)

Keywords: pneumothorax
food effect on ceftibuten/vnrx-7145 in healthy participants

Conditions: Pharmacokinetics

Summary: this is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). the pharmacokinetics (pk) of the inactive prodrug vnrx-7145, its active parent drug vnrx-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/vnrx-7145.


Eligibility criteria:
inclusion criteria: * healthy adults 18-65 years * males or non-pregnant, non-lactating females * body mass index (bmi): ≥18.5 kg/m2 and ≤32.0 kg/m2 * laboratory values meeting defined entry criteria exclusion criteria: * history of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug * conditions that potentially alter absorption and/or excretion of orally administered drugs * congenital or acquired immunodeficiency syndrome * positive alcohol, drug, or tobacco use/test
study of intrahepatic arterial infusion of tg6002 in combination with 5-fc in patients with metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: this study will include two parts: * phase i part is a dose-escalation study to assess the safety of increasing doses of tg6002 in combination with oral flucytosine (5-fc) in consecutive cohorts of 3 to 6 patients with colorectal cancer and unresectable liver metastases according to a 3+3 design * phase iia part is an extension of the phase i part at the recommended phase ii dose to evaluate the efficacy of tg6002 in combination with oral flucytosine (5-fc) in patients with colorectal cancer and unresectable liver metastases. in both parts, tumor response will be evaluated on local assessment using recist 1.1. all patients will be followed until disease progression, death due to any cause or the date of data cut-off, whichever occurs first.


Eligibility criteria:
inclusion criteria: 1. unresectable metastatic crc with at least one measurable liver metastasis 2. at least one liver metastasis amenable to biopsy 3. patients previously exposed to fluoropyrimidine-based chemotherapy 4. (phase i) patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy, or, in the uk only, patients on or entering a period of clinical observation without treatment 5. (phase iia) patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy. 6. aged ≥18 years 7. estimated life expectancy \>3 months 8. ecog performance status ≤1 exclusion criteria: 1. predominant extrahepatic disease 2. symptomatic brain metastases or meningeal tumors 3. any contraindication to intrahepatic artery infusion procedure 4. received other investigational therapy or had surgery within 4 weeks of treatment initiation which would interfere with study treatment 5. received locoregional therapy for crc within 4 weeks prior to treatment initiation 6. severe uncontrolled coagulopathy or anticoagulant medication 7. antiviral therapy active on vaccinia virus, e.g., ribavirin, interferon/pegylated interferon 8. immunosuppression due to immunosuppressive medication including steroids equivalent to prednisolone \>10mg/day taken for more than 4 weeks within 3 months prior to tg6002 treatment initiation 9. patients treated with 3 or more anti-hypertensive agents and/or patients with signs of advanced hypertensive disease, such as left ventricular hypertrophy, hypertensive encephalitis or history of hemorrhagic stroke.
hand incision study

Conditions: Hand Surgery

Summary: the cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. a patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * able to provide consent * undergoing either trigger finger release or carpal tunnel release exclusion criteria: * patients \< 18 years old * unable to provide consent * unable to comply with follow up requirements
newborn brain test (nbt)

Conditions: Seizures Newborn; Brain Injuries

Summary: the aim of the overall project is to develop the newborn brain test (nbt), a novel platform to detect abnormal brain activity in infants at birth through an automated ai assessment. easy to interpret results, provided in less than 15 minutes, will allow for immediate follow up by a medical team when abnormal brain function is detected. nbt has been developed by infant's study partner cergenx (ucc spinout company), who sponsors the study. infant is responsible for the clinical aspect of the project and will conduct a feasibility study of the device as well as a larger pivotal investigation.

eeg activity will be recorded using the standard ce marked portable eeg amplifier with four electrodes on the scalp. the test will be controlled using a tablet. the captured waveforms will be sent to the cloud where the nbt artificial intelligence (ai) algorithm analyses eeg activity, analyses the data and decides whether the test was or was not completed successfully. the test takes approximately 15 minutes to complete. the device has been trained with eeg data from full term infants. it is not a diagnostic test, simply a screener. the eeg and anonymised patient data collected during the nbt test will be processed and stored in the nbt secure aws infrastructure. during the feasibility study, the result (eeg reading or result of ai algorithm) from the device will not be available to the research team so as not to influence clinical practice.

Eligibility criteria:
inclusion criteria: * all neonates≥ 37 and ≤45 weeks gestational age * parental informed consent exclusion criteria: * any infant with head trauma or broken skin on the scalp * informed consent not obtained.
study of the quality of life of patients treated by heavy surgery as part of an enhanced recovery at beau soleil clinic- qualichir

Conditions: Enhanced Recovery After Surgery; Cystectomy

Summary: heavy and oncological surgery is undergoing a major evolution. some surgical dogmas are falling and care is better rationalized. the interactions between the patient and the caregivers on the other hand, and from the caregiver to the caregiver are favored. thus was born, about 10 years ago, the principle of enhanced recovery after surgery (eras). but recovery has improved in the patient in the best possible shape in the operating room, and, during the gesture, minimize the negative effects of surgery and anesthesia. finally, postoperatively, to re-empower the patient as quickly as possible. the interest of this study is the benefit of the quality of life of the patient being treated for cystectomy as part of an enhanced recovery program. this is to argue the diffusion of this program and the care teams for its realization.


Eligibility criteria:
inclusion criteria: * patients with an indication of cystectomy validated by the surgical team and if there is an oncological indication by the multidisciplinary meeting of onco-urology. * patient affiliated to a social security scheme * patient classified asa from 1 to 3 * patient informed and having accepted the principle of enhanced recovery after surgery exclusion criteria: * patients classified asa ≥4 * patients with severe or poorly balanced associated conditions (diabetes, long-term corticosteroid therapy, severe undernutrition, cirrhosis, immunosuppression, cardiac disease), contraindications to enhanced recovery after surgery (eras) may be temporary if they are corrected. * patients who can not comply with the eras protocol because they do not understand the language or cognitive disorder. * vulnerable people (article l 1121-6 of the csp) * majors subject to legal protection or unable to express their consent (article 1121-8 of the csp)
evaluation of azacitidine in transfusion dependent patients with low-risk myelodysplastic syndrome (mds) or chronic myelomonocytic leukemia (cmml)

Conditions: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Summary: azacitidine has proved prolonged overall survival in patients with high-risk mds. minor pilot studies have shown that treatment with azacitidine can induce transfusion independency in previous transfusion dependent patients with low-risk mds. this study will evaluate the effect of azacitidine in transfusion dependent patients with low-risk mds (ipss low or int-1) or low risk cmml. included patients should first have failed, or considered not being eligible to, treatment with epo +/- g-csf. our hypothesis is that azacitidine can lead to transfusion independency in this group of patients. those patients who do not respond to treatment with azacitidine alone, will be given treatment with the combination of azacitidine and epo where our hypothesis is that azacitidine can restore sensitivity to epo.


Eligibility criteria:
inclusion criteria: * must be 18 years of age at the time of signing the informed consent form * mds at ipss low or int-1, or mixed mds/mpd; either cmml with \< 10% marrow blasts or rars-t * patients with high or intermediate probability for response according to the predictive model (see hellstrom-lindberg et al, br j haematol 99:344-51 1997)should be refractory to epo / darbepoetin (equivalent to \> 60 000 u of epo / week for \> 8 weeks) followed by epo + g-csf for \> 8 weeks, or biosimilar drugs in equipotent doses, or epo + g-csf upfront for 8 weeks. patients with low probability for response according to the predictive model, could be included without prior epo/g-csf treatment * transfusion need \>4 units over the last 8 weeks, or \>8 units over the last 26 weeks. * subject has signed the informed consent document. * men and women of childbearing potential must use effective contraception during, and for up to 3 months after treatment. exclusion criteria: * pregnant or lactating females. * patients who are eligible for curative treatment * expected survival less than 24 weeks. * symptomatic thrombocytopenia / active bleeding * patients with jak-2 positive rars-t if eligible for new investigational drugs * serum biochemical values as follows 1. serum creatinine \>2.0 mg/dl (177 micromol/l) 2. serum aminotransferase (ast)/serum glutamic-oxaloacetic transaminase (sgot) or alanine transaminase (alt)/serum glutamate pyruvate transaminase (sgpt) \>3.0 x upper limit of normal (uln) 3. serum total bilirubin \>1.5 mg/dl (26 micromol/l) * uncontrolled systemic infection * considered not capable of following the study protocol

Keywords: myelodysplastic syndrome chronic myelomonocytic leukemia transfusion therapy transfusion dependency hypomethylating therapy azacitidine dna-methylation epigenetic modifications
real-world patient characteristics, treatment patterns, and clinical outcomes among patients with braf-positive metastatic melanoma

Conditions: BRAF-positive Metastatic Melanoma

Summary: this was a retrospective, longitudinal, observational study conducted using the flatiron health electronic health record (ehr)-derived database. braf+ advanced or metastatic (i.e., stage iii or iv) melanoma patients treated at oncology practices across the us were identified for potential inclusion. all included patients were aged ≥18 years and required to have a diagnosis of melanoma (international classification of diseases (icd)-9 172.x \& icd-10 c43 or d03x), a pathologic unresectable stage iii or iv diagnosis, subsequent first-line (1l) treatment with either immunotherapy (io) (nivolumab, pembrolizumab, ipilimumab + nivolumab) or targeted therapy (tt) dafratenib + trametinib (dab/tram) on or after 01 january 2014, and evidence of a braf-positive result at any point in time.


Eligibility criteria:
inclusion criteria: * diagnosis of melanoma (icd-9 172x \& icd-10 c43 or d03x) * ≥2 documented clinical encounters on different days in the flatiron network on or after 01 january 2011 * pathologic unresectable stage iii or iv at initial diagnosis after 01 january 2011, or earlier stage disease accompanied by development of a first locoregional recurrence after 01 january 2011 * diagnosis of mm after 01 january 2011 * evidence of a braf-positive result at any point in time * treatment with one of the following 1l therapies on or after 01 january 2014: * io (nivolumab, pembrolizumab, or ipilimumab + nivolumab) * tt (dab/tram) * at least 18 years of age at the time of initiation of 1l therapy * at least 6-months of continuous follow-up from the time of initiation of 1l therapy exclusion criteria: * lacking relevant unstructured documents (i.e., information such as free text from a physician note or pathology report that is captured systematically during the data abstraction process) in the flatiron health database * evidence of non-skin melanoma (ocular, subungual, mucosal, palmar, plantar) * documented receipt of a clinical study drug, defined as any uncancelled order, administration, or oral episode for a clinical study drug for cancer at any time prior to or during 1l treatment * presence of leptomeningeal disease (icd-9 198.4 \& icd-10 c79.32 or c79.49)
efficacy of ubiquinone and combined antioxidant therapy in non-proliferative diabetic retinopathy

Conditions: Non-proliferative Diabetic Retinopathy; Diabetes Mellitus Type 2

Summary: the purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant therapy on progression, clinical regression, oxidative stress markers and mitochondrial dysfunction in non-proliferative diabetic retinopathy.

the investigators are interested in demonstrating the efficacy of ubiquinone and combined antioxidant therapy in the pharmacological management of diabetic retinopathy since early stages.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * patients with non proliferative diabetic retinopathy * glycated hemoglobin \< 12.0% * signing of informed consent exclusion criteria: * patients with clinically significant macular edema * patients with diabetic retinopathy advanced lesions that have required or require specific treatment (laser, vitrectomy) * pretreatment with argon laser or excimer laser ophthalmology surgery * any other associated ocular pathology (glaucoma, cataracts, changing cornea dystrophy, macular degeneration) * pregnancy, lactation, inadequate use of contraception * antioxidant drug and/or supplements six months previous to enrollment * renal and/or hepatic failure * age under 30 or over 75 years * severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vasculopathy) * blood dyscrasias * have or have had cancer or other serious illness * neurodegenerative process * allergy to vitamins

Keywords: oxidative stress mitochondrial dysfunction ubiquinone antioxidant combined therapy diabetic retinopathy
male involvement in antenatal care and the prevention programme of mother-to-child transmission of hiv in uganda

Conditions: HIV Infection

Summary: hiv /aids is a major public health problem in uganda. the prevention of mother to child transmission of hiv/ aids (pmtct) was launched in uganda in november 2001 and in mbale hospital in may 2002. currently, pmtct services have been integrated into mainstream antenatal care services throughout the country. though engaging men as partners is a critical component in the pmtct programme, their involvement has been low. measures to increase male partner involvement in the pmtct programmes have not been explored in uganda. objectives: to determine the effect of a written invitation letter to the spouses of women, attending their first antenatal visit on: (a) couple attendance at subsequent antenatal clinic visits; and (b) couple acceptance of hiv testing. study site: the study will be carried out at mbale regional referral hospital in eastern uganda study design: a randomised clinical trial among 1060 (530 intervention and 530 control) new antenatal attendees. the intervention will be a written invitation letter to their spouses. outcome measures: the main outcome measure is the proportion of pregnant women who come with their partners for anc at the subsequent antenatal visit. utility: the results of this study will be utilised in re-orienting the anc services to encourage male participation and hopefully improve the uptake of the pmtct services at mbale regional referral hospital.


Eligibility criteria:
inclusion criteria: * new antenatal mothers (attendees) at mbale regional referral hospital * acceptance to attend at least two subsequent antenatal visits at mbale hospital exclusion criteria: * women attending with their spouses at the first anc visit * refusal to take the letter to her spouse * women with inaccessible spouses

Keywords: prevention of mother-to-child transmission of hiv-1